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AAA study


- candidate number22809
- NTR NumberNTR5420
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-sep-2015
- Secondary IDsNTS.1.P/H, Nutricia Research B.V. 
- Public TitleAAA study
- Scientific TitleAmino Acid bioavailability of different proteins
- ACRONYMAAA study
- hypothesisThe administered protein mix is related to a faster postprandial amino acid bioavailability compared to a single protein as measured by the t of the iAUC.
- Healt Condition(s) or Problem(s) studiedHealthy elderly
- Inclusion criteria1. Age 65 years or older
2. BMI from 20 through 30 kg/m2
3. Willingness and ability to comply with the protocol
4. Written informed consent
5. Be judged by the investigator to be in good health
- Exclusion criteria1. Any gastrointestinal (GI) disease or surgery that interferes with GI function
2. Known renal or hepatic failure
3. Known or suspected Diabetes Mellitus (fasting glucose level 7.0 mmol/L)
4. (History of) any cancer with the exception of basal cell carcinoma
5. Fever in the last 7 days prior to Visit 1
6. Haemoglobin in men <7.5 mmol/L and in women <7.0 mmol/L
7. Use of antibiotics, or anticonvulsants, or prokinetics, or antacids or any medication influencing gastric acid production, or oral and systemic use of anticoagulants, or corticosteroids, or laxatives, or growth hormone, or testosterone, or immunosuppressants or insulin within 3 weeks of Visit 1
8. Known severe weight loss (> 3 kg in last 3 months)
9. Participation to a weight loss program
10. Use of protein containing or amino acid containing nutritional supplements within one week of Visit 1
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 3-sep-2015
- planned closingdate15-nov-2015
- Target number of participants13
- InterventionsDuration of intervention: 5 weeks
Intervention group: 5 weeks
Control group: 5 weeks
- Primary outcomeThe primary outcome parameter in this study is the time to reach half incremental area under the curve (t iAUC) for the sum of all amino acids (total AA) comparing product A to product B.
- Secondary outcomeThe secondary outcome parameters of this study are:
The (incremental) maximum amino acid concentration ((i)Cmax), (incremental) area under the concentration curve ((i)AUC) and t iAUC comparing all study products for total AA
Gastric emptying half time (t1/2), Cmax, and time until Cmax is reached (Tmax) and AUC (plasma concentrations of paracetamol) comparing all study products
Satiety questionnaire
- TimepointsTime points of the outcome: V1 (baseline) until V6 (week 6).
- Trial web siteNot applicable
- statusplanned
- CONTACT FOR PUBLIC QUERIES Zandrie Hofman
- CONTACT for SCIENTIFIC QUERIES Monique Visser
- Sponsor/Initiator Nutricia Research BV
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research Foundation
- PublicationsNot applicable
- Brief summaryThe purpose of the current study is to gain knowledge regarding amino acid bioavailability of different proteins and protein mixes. Secondly, we aim to study the impact of different proteins on gastric emptying and postprandial fullness and satiety.

This is a randomized, controlled, double-blind, crossover, single-centre study which aims to include 13 healthy older subjects (age 65 years or older) with a minimum of 4 subjects for each sex.

Six different study products will be investigated: - 4 seperate proteins
- two mixes of these proteins
- Main changes (audit trail)
- RECORD2-sep-2015 - 4-nov-2015


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